Microbiome Test for the Detection of Colorectal Polyps

Biotax Labs

Status: Unknown

Conditions: Colon Polyp

Treatments: Diagnostic Test: biotax

Study type: Interventional

Funder types: Industry

Identifiers

NCT05060757

Biotax_001

Details and patient eligibility

About

The main goal of this trial is to validate a new method for colorectal polyp screening based on stool microbiome signatures. 600 Individuals who are scheduled / planned to undergo a colonoscopy will be recruited for this study and a stool sample and an optional saliva sample will be collected.

Analyze process will be conducted on the microbiome of the samples given.

Full description

Colorectal cancer (CRC) is the second cause of cancer death in the US. The pathogenesis of CRC is complex, involving a progressive transition of the healthy colonic mucosa to pre-cancerous polyps, and eventually to CRC. One of the factors that are proposed to cause this 'adenoma-carcinoma sequence' is the dysbiosis of the gut microbiome.

The gut microbiota has been identified as a potential screening biomarker for CRC, since studies have reported specific bacterial taxa and/ or microbial signatures as important factors in the etiology of CRC.

Hypothesis:

comprehensive and cutting-edge metagenomic analysis of the fecal microbiome of individuals with colonic polyps vs. patients without polyps will identify microbial signatures associated with colonic polyps and will define these microbial signatures as biomarkers and risk factors for CRC.

method:

• Collect data (anthropometric, demographic, dietary, lifestyle habits, medical and family history) and stool & optional Saliva sample for microbiome analysis from a cohort of 600 colonoscopies screened individuals.
• Analyze this data with an aim to utilize advanced artificial intelligence and machine-learning techniques to classified microbiome signatures, which are correlated to colonoscopy (and to histological) results.
• Blinded Validation - A sub-cohort of 300 individuals (who are part of the 600 individuals) that were not used to classify the biomarkers signatures will be used to validate the diagnosis model.

Data analysis:

The stool and optional Saliva samples will be sent to metagenomic sequencing, thereby generating FASTQ libraries of the reads found in the stool & saliva samples. These files will be analyzed by the BiotaX diagnostics platform.

No Human DNA analysis will take place at this clinical study. Only a microbial analysis will take place.

Enrollment: 600 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females.
2. Age: 45-70 years, inclusive.
3. Patients without any incapacitating systemic disease
4. Able to comprehend and provide informed consent.
5. Patients who are scheduled / planned to undergo a colonoscopy, preferably: participants who are undergoing a colonoscopy as a diagnostic surveillance.

Exclusion criteria

1. Subject has a history of colorectal cancer (CRC)

2. Subject has a diagnosis or medical history of any of the following conditions:

   • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
   • Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")

3. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease.

4. Patients with incapacitating systemic disease

5. Any use of antibiotics within one months prior to colonoscopy.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

colonoscopy

Experimental group

Description:

Participants will be patients undergoing colonoscopy

Treatment:

Diagnostic Test: biotax